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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000366-66 | EudraCT Number |
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Gilead has made the decision to close the study due to enrollment challenges
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The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib 150 mg BID | Experimental | Participants will receive idelalisib 150 mg twice daily continuously. For participants enrolled prior to protocol amendment 5: Based on the independent review committee (IRC) response assessment, participants may be discontinued from the study or may receive blinded or open-label idelalisib 150 mg twice daily. |
|
| Idelalisib 100 mg BID | Experimental | Participants will receive idelalisib 100 mg twice daily continuously. Based on the IRC response assessment, participants may either be dose escalated to open-label 150 mg twice daily or maintain blind and continue on idelalisib 100 mg twice daily. As of protocol amendment 5, enrollment to this arm has been closed. |
|
| Idelalisib 150 mg BID INT | Experimental | Participants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Idelalisib tablet administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow. | Randomization up to end of treatment (maximum duration: 73.5 months) |
| Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced. | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR: interval from first documentation of CR/PR to earlier of first documentation of disease progression (PD) by independent review committee (IRC)/death from any cause. PR:No evidence of new disease,≥50% decrease from baseline in SPD of index lesions,no increase in non-index disease, no increase in liver/spleen size,no new liver/spleen enlargement; Persistence of bone marrow involvement in participant who meets other CR criteria. CR: No evidence of new disease,regression of all index nodal lesions to normal size (large nodes:≤1.5 cm in LD;small nodes:≤1.0 cm in LD,≤1.0 cm in LPD), regression to normal of all nodal non-index disease,disappearance of all detectable extra-nodal index,non-index disease,normal spleen and liver size, no new liver/spleen enlargement; PD: New node of >1.5 cm or >1.0 to ≤1.5 cm in LD, >1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion,new non-index disease,increase by 50% in SPD of index lesions,LD of individual node/extra-nodal mass. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calvary Norht Adelaide Hosptial | Woodville South | South Australia | 5011 | Australia | ||
| Royal Victoria Regional Health Centre |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
18 months after study completion
A secured external environment with username, password, and RSA code.
145 participants were screened.
Participants were enrolled at study sites in Australia, Canada, Europe, Israel, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib 150 mg BID | Participants received idelalisib 150 mg tablets, orally, twice daily (BID), continuously for up to maximum 33.5 months. |
| FG001 | Idelalisib 100 mg BID | Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2021 | May 25, 2023 |
As of protocol amendment 5, the Idelalisib 100 mg arm is closed to enrollment.
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Double-blind: Prior to protocol amendment 5; Open-label: Participants enrolled as of protocol amendment 5
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| From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months) |
| Overall Response Rate (ORR) by Week 24 | ORR by Week 24 is defined as the percentage of participants who achieve a PR or CR by Week 24. PR criteria: No evidence of new disease, a 50% decrease from baseline in SPD of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in LD for large nodes and ≤1.0 cm in LD, ≤1.0 cm in LPD for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow. | First dose date up to Week 24 |
| Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib | TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants are counted at the highest AE grade experienced. | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
| Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days. Laboratory abnormalities included hematology and serum chemistry parameters. Clinically significant laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The number of participants with any post-baseline abnormal laboratory value in Grade 1-4 categories are reported. | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
| Time to Onset of Adverse Events of Interest (AEIs) | Time to onset of AEIs is defined as the interval (in months) from the start of idelalisib treatment to the first documentation of start of AEI. AEIs included grade ≥ 3 diarrhea/colitis, rash, febrile neutropenia, infection, and any grade of: Pneumonitis, bowel perforation, progressive multifocal leukoencephalopathy (PML), Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) infection, and organizing pneumonia. | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
| Progression-Free Survival (PFS) | PFS is defined as the interval (in months) from randomization to the earlier of the first documentation of PD by IRC or death from any cause. PD criteria: New node of >1.5 cm or >1.0 cm to ≤1.5 cm in LD, >1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion, new non-index disease, increase by 50% in SPD of index lesions, LD of individual node/extra-nodal mass. | Randomization up to PD or death from any cause (maximum duration: 73.5 months) |
| Overall Survival (OS) | OS is defined as the interval (in months) from randomization to death from any cause. | Randomization up to death from any cause (maximum duration: 73.5 months) |
| Trough Plasma Concentration of Idelalisib | Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48 |
| Peak Plasma Concentration of Idelalisib | 1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48 |
| Barrie |
| L4M 6M2 |
| Canada |
| Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika | Brno | 625 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 10034 | Czechia |
| Fakulni newmcince v Motole, Onkologicka klinika 2. LF UK a FN Motol | Prague | 150 06 | Czechia |
| Centre Hospitalier d'Avignon-Hopital Henri Duffaut | Avignon | 84000 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33077 | France |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| Hopital Saint Antoine | Paris | 72012 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Centre Hospitalier Universaitaire de Poit iers-Pole Regional de Cancerlogie | Poitiers | 86021 | France |
| Centre Hospitalier de Tours-Hopital Bretoneau Centre Regional de Cancerologie Henry Kaplan | Tours | 37044 | France |
| Clinique Louis Pasteur | Vandoeuvre-lés-Nancy | 54511 | France |
| Carmel Medical Center | Haifa | 34362 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| ASST Spedali Civili | Brescia | 25123 | Italy |
| Ospedale Policlinico San Martino IRCCS-Clinica Ematologica | Genoa | 16132 | Italy |
| Azienda Policlinico San Martino | Genova | 16132 | Italy |
| Azienda Ospedaliera Cardinale G Panico di Tricase-Unita Operativa Complessa di Ematologia e TMO | Lecce | 73039 | Italy |
| Azienda Ospedaliera Vito Fazzi Unita Operativa di Ematologia | Lecce | 73100 | Italy |
| Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Dipartimento di Oncologia Medica | Meldola | 47014 | Italy |
| IRCCS Ospendale San Raffaele | Milan | 20132 | Italy |
| SCDU Ematologia e Terapie Cellulari Azienda Ospedaliera Ordine Mauriziano di Torino | Orbassano | 10043 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello | Palermo | 90146 | Italy |
| Azienda Unita Sanitaria Locale di Ravenna, U.O di Ematologia | Ravenna | 48121 | Italy |
| Ospedale degli Infermi-Oncoematologia | Rimini | 47900 | Italy |
| Fondazione Policlinico Tor Vergata-UOC Patologie Linfoproliferative | Rome | 00133 | Italy |
| Ospedale S. Eugenio | Rome | 00144 | Italy |
| Dipartimento di Ematologia ed Oncoematolgia - S.C Ematolgia | Torino | 10126 | Italy |
| A.S.U. Integrata Santa Maria della Misericordia | Udine | 33100 | Italy |
| Szpitale Wojewodzkie w Gdyni Sp. z o.o. | Gdynia | 81-519 | Poland |
| PRATIA Onkologia Katowice | Katowice | 40-519 | Poland |
| Malopolskie Centrum Medyczne | Krakow | 30-510 | Poland |
| Wojewodzki Szpital Specjalistyczny w Legniicy | Legnica | 59-220 | Poland |
| Gabinety Lekarskie Hema | Lublin | 20-090 | Poland |
| Szpital Wojewodzki w Opolu Sp. z o.o. | Opole | 45-372 | Poland |
| Instytut Hematologii i Transfuzjologii, Klinika Hematologii | Warsaw | 02-776 | Poland |
| Centrum Onkologii Instytut im.Marii Sklodowskiej Curie | Warsaw | 02-781 | Poland |
| Klinika Hematologii Nowotworow Kriwi i Transplantacji Szpiku | Wroclaw | 50-367 | Poland |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare | Baia Mare | 430031 | Romania |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Institut Catala d'Oncologia Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital General Universiario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC) | Madrid | 28050 | Spain |
| Hospital Puerta de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Hospital Genereal Universitario Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 07198 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Mutua Terrassa | Terrassa | 08221 | Spain |
| CEIm-Regional De La Comunidad De Madrid | Valencia | 46026 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| East Kent Hospitals University NHS Foundation Trust | Canterbury | CT1 3NG | United Kingdom |
| London North West University Healthcare NHS Trust | Harrow | HA1 3UJ | United Kingdom |
| Clatterbridge Cancer Centre NHS Foundation Trust | Liverpool | L7 8XP | United Kingdom |
| Barts Health Trust | London | EC1A7BE | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| St George's Hospital NHS Trust | London | SW17 0QT | United Kingdom |
| The Pennine Acute Hospital NHS Trust | Oldham | OL1 2JH | United Kingdom |
| Torbay and South Devon NHS Foundation Trust | Torquay | TQ2 7AA | United Kingdom |
| FG002 | Idelalisib 150 mg BID INT | Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (intermittent [INT] dosing schedule) in each 28-day cycle for up to maximum of 24.6 months. |
| COMPLETED |
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| NOT COMPLETED |
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|
Safety analysis set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib 150 mg BID | Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months. |
| BG001 | Idelalisib 100 mg BID | Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months. |
| BG002 | Idelalisib 150 mg BID INT | Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow. | Intent-to-Treat (ITT) analysis set included all participants who were randomized regardless of whether they received any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization up to end of treatment (maximum duration: 73.5 months) |
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| Primary | Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
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| Secondary | Duration of Response (DOR) | DOR: interval from first documentation of CR/PR to earlier of first documentation of disease progression (PD) by independent review committee (IRC)/death from any cause. PR:No evidence of new disease,≥50% decrease from baseline in SPD of index lesions,no increase in non-index disease, no increase in liver/spleen size,no new liver/spleen enlargement; Persistence of bone marrow involvement in participant who meets other CR criteria. CR: No evidence of new disease,regression of all index nodal lesions to normal size (large nodes:≤1.5 cm in LD;small nodes:≤1.0 cm in LD,≤1.0 cm in LPD), regression to normal of all nodal non-index disease,disappearance of all detectable extra-nodal index,non-index disease,normal spleen and liver size, no new liver/spleen enlargement; PD: New node of >1.5 cm or >1.0 to ≤1.5 cm in LD, >1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion,new non-index disease,increase by 50% in SPD of index lesions,LD of individual node/extra-nodal mass. | Participants in the ITT analysis set who achieved CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | months | From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months) |
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| Secondary | Overall Response Rate (ORR) by Week 24 | ORR by Week 24 is defined as the percentage of participants who achieve a PR or CR by Week 24. PR criteria: No evidence of new disease, a 50% decrease from baseline in SPD of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in LD for large nodes and ≤1.0 cm in LD, ≤1.0 cm in LPD for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow. | Participants in the ITT analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First dose date up to Week 24 |
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| Secondary | Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib | TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants are counted at the highest AE grade experienced. | Participants in the safety analysis set were analyzed. | Posted | Count of Participants | Participants | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
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| Secondary | Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days. Laboratory abnormalities included hematology and serum chemistry parameters. Clinically significant laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The number of participants with any post-baseline abnormal laboratory value in Grade 1-4 categories are reported. | Participants in the safety analysis set with available data were analyzed. | Posted | Count of Participants | Participants | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
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| Secondary | Time to Onset of Adverse Events of Interest (AEIs) | Time to onset of AEIs is defined as the interval (in months) from the start of idelalisib treatment to the first documentation of start of AEI. AEIs included grade ≥ 3 diarrhea/colitis, rash, febrile neutropenia, infection, and any grade of: Pneumonitis, bowel perforation, progressive multifocal leukoencephalopathy (PML), Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) infection, and organizing pneumonia. | AEIs data was not collected for analysis. | Posted | First dose date up to 30 days after last dose of study drug (maximum 64.6 months) |
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| Secondary | Progression-Free Survival (PFS) | PFS is defined as the interval (in months) from randomization to the earlier of the first documentation of PD by IRC or death from any cause. PD criteria: New node of >1.5 cm or >1.0 cm to ≤1.5 cm in LD, >1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion, new non-index disease, increase by 50% in SPD of index lesions, LD of individual node/extra-nodal mass. | Participants in the ITT analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | Randomization up to PD or death from any cause (maximum duration: 73.5 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the interval (in months) from randomization to death from any cause. | Participants in the ITT analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | Randomization up to death from any cause (maximum duration: 73.5 months) |
|
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| Secondary | Trough Plasma Concentration of Idelalisib | Pharmacokinetic (PK) analysis set included participants who received at least 1 dose of study drug and had at least 1 sample with detectable drug concentration. Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48 |
|
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| Secondary | Peak Plasma Concentration of Idelalisib | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/ml | 1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48 |
|
|
All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
All-Cause Mortality: All enrolled analysis set included all participants who received a study participant identification number after screening and was used for participant enrollment summary and data listings, unless otherwise specified.
Adverse Events: Safety analysis set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idelalisib 150 mg BID | Participants received idelalisib 150 mg tablets, orally, BID, continuously for up to maximum 33.5 months. | 20 | 47 | 31 | 47 | 44 | 47 |
| EG001 | Idelalisib 100 mg BID | Participants received idelalisib 100 mg tablets, orally, BID, continuously for up to maximum 63.6 months. | 12 | 27 | 19 | 27 | 24 | 27 |
| EG002 | Idelalisib 150 mg BID INT | Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months. | 6 | 22 | 11 | 21 | 16 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Klebsiella test positive | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2022 | May 23, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552946 | idelalisib |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Other or More Than One Race |
|
| Poland |
|
| Spain |
|
| United Kingdom |
|
| France |
|
| Czechia |
|
| Israel |
|
| Australia |
|
| Canada |
|
| Romania |
|
|
|
| OG002 | Idelalisib 150 mg BID INT | Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months. |
|
|
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months.
|
|
|
|
Participants received idelalisib 150 mg tablets, orally, BID for 21 days and 7 days off-treatment (INT dosing schedule) in each 28-day cycle for up to maximum of 24.6 months. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Participants |
|
|
|